Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Type 1 Diabetes; Juvenile Onset Diabetes Mellitus; Autoimmune Diabetes; Insulin Dependent Diabetes

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01559025

CLAF237ABR01T

Details and patient eligibility

About

The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months).

The secondary objectives are:

1. To define the immune and inflammatory profile
2. To define the secretion of glucagon and GLP-1
3. To assess the glycemic variability

Full description

Clinical and autopsy studies show that up to 30% of patients with type 1 diabetes mellitus show a detectable β-cell function at clinical diabetes. The preservation of this endogenous insulin production, even if it is small, can have a great impact on the evolution of long-term disease through improving glycemic control, reducing chronic diabetes complications and hypoglycemia. Strategies for preventing the loss of beta cell are based on stopping the autoimmune process and also in the preservation and regeneration of beta cells. Currently have been questioned the potential use of GLP-1 for new-onset type 1 diabetes. The justification for this issue is based on the fact that this class of drugs, besides acting on insulin secretion and glucose regulation, may be effective to preserve and expand beta cell mass, which has been shown in animals. Ideal candidates for this treatment are newly diagnosed patients who still have significant viable beta cell mass.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 to 35 years
• Up to 6 months of clinical diagnosis
• Fasting C-peptide ≥ 0.25 ng / ml
• HbA1C <9.0%
• Positive autoantibodies (anti-GAD, Anti-Insulin and Anti-IA2)
• Without chronic complications

Exclusion criteria

• Hepatic, cardiac, pulmonary and hematologic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Insulin therapy

No Intervention group

Description:

Patients will receive the conventional treatment with insulin

Vildagliptin

Active Comparator group

Description:

Patients will receive vildagliptin besides the conventional treatment with insulin

Treatment:

Drug: Vildagliptin